Speakers

Risk Management Through Product Life Cycle: An Educational Forum held in Arlington, Texas, on April 2, 2010. 

	Al Alonso represents the Regulatory Affairs Professionals Society (RAPS) in FMDIC. He joined DJO Surgical in July 2003 as the VP Quality Assurance, Clinical/Regulatory Affairs. Prior to that he worked 23 years with Carbomedics, Inc., a manufacturer and marketer of implantable cardiovascular devices, as the VP Quality Assurance, Clinical/Regulatory Affairs and also as the VP Quality Management. He has a Bachelor of Science degree in Chemistry from The University of Texas at Austin.
	Regina Barrell has a BS degree in Environmental Science/Chemistry, Purchase College; MS degree Environmental Science, University of Colorado. She began her career with the FDA in 1987 as a Chemist in the Denver District’s Laboratory. In 1992, she was promoted to the position of Compliance Officer, specializing primarily in medical device and biologics cases. In this capacity, she handled some of the District’s complex regulatory cases, as well as provided compliance training to newly-hired investigators and quality assurance functions for the laboratory. From 1999 through May 2000, she acted as a Supervisory Investigator, managing a group of eight investigators. Her responsibilities included supervising the inspections of various regulated industries including food, drug, biologic and medical device firms. She returned to her role as a Compliance Officer in the Denver District Office from June 2000 through May 2008, at which time she was promoted to her current role as Senior Case Review Expert in the Office of Enforcement’s Division of Compliance Management and Operations.
	Ricki Chase is a Supervisory Investigator in the Salt Lake City Resident Post of the FDA Denver District and the District’s medical device program manager. Before becoming a Supervisor, Ms. Chase was the District’s Medical Device Specialist. Her primary experience has been in the drug and medical device programs, completing domestic and foreign inspections and developing regulatory cases. Prior to coming to FDA, Ms. Chase was an Investigator for the Texas Department of Health’s Drug and Medical Devices Division. She has a B.S. and an M.S. in Biology from the University of Texas at Arlington.
	William A. Hyman, Sc.D., is a professor of biomedical engineering at Texas A&M University (TAMU, College Station, TX). He holds an ScD in engineering mechanics and an MS in engineering mechanics from Columbia University, and a BSME in mechanical engineering from The Cooper Union. He has served as a consultant for FDA, the National Science Foundation, the National Institutes of Health, the U.S. Army, the General Accounting Office, for medical device companies, and in patent and personal injury litigation. He holds memberships in the American Society for Testing and Materials (ASTM), the American College of Clinical Engineering, the Association for the Advancement of Medical Instrumentation, the Biomedical Engineering Society, and the Human Factors and Ergonomics Society technical group on medical systems and functionally impaired populations. Hyman serves on the ASTM committees on surgical implants and medical devices and is a board member of the U.S. Board of Examiners for Clinical Engineering, and of the ACCE Healthcare Technology Foundation. He is a member of the Dallas District FDA/Industry Coalition, and is an editor of the Journal of Clinical Engineering. Dr. Hyman is a registered professional engineer in Texas.
	Bonnie Pierson is a native of North Carolina. She completed her undergraduate studies at North Carolina State University (NCSU). More recently, she received an M.S. in Biomedical Engineering from a joint program between NCSU and the UNC Chapel Hill. Her experience is primarily research-oriented; however, her background includes device design and prototype manufacturing. Currently, Bonnie is working out of the FDA’s Kansas District Office as an Investigator, focusing in medical device inspections.
	Reynaldo R. Rodriguez Jr is the Dallas District Director. He has been in his current position since February, 2008. Prior to this position, he served as the Compliance Branch Director in Dallas, a Compliance Officer, Supervisory Investigator, and Investigator. He began his career with FDA in 1983, and has a wide breadth of inspectional and compliance experience across all FDA program areas. Mr. Rodriguez received his Bachelor of Arts degree in Biology/Chemistry from St. Mary’s University, San Antonio, Texas, in 1983, and received his Master of Arts degree in Public Administration from Webster University, St. Louis, Missouri, in 1986.
	Joseph Tartal has worked at the FDA since 2006. He is currently the Technical Branch Chief for the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) in the Center for Devices and Radiological Health (CDRH). This division is responsible for assisting manufacturers with compliance questions and facilitating communication between the medical device industry and the agency. Prior to coming to FDA, Mr. Tartal served as a Quality Assurance Manager for a small medical device manufacturer where he was responsible for implementing and maintaining a quality system compliant with FDA, EU and ISO regulatory requirements. Mr. Tartal has more then 15 years experience in the medical device industry that encompasses medical device pre-market submission and quality systems. Mr. Tartal holds a Bachelors degree in Biology which he received from Slippery Rock University in Pennsylvania.
	Julie Thomas has been Director of Quality for LabNow since February 2008. She is responsible for assuring that LabNow meets the requirements of domestic and international regulatory directives for their products. After graduating with a BS degree in chemistry and biology, she began working for McNeil Consumer Products, a subsidiary of Johnson & Johnson, where she advanced through positions in quality, manufacturing and engineering, and ultimately served as plant manager. During her tenure with J&J, Julie received an MS in manufacturing management, became a Certified Quality Engineer and received certification as a Six Sigma Black Belt. She subsequently served as Quality Manager with Hospira, a large volume parenteral manufacturer. Julie was responsible for quality operations at the Austin manufacturing site, including compliance, record management, validation, QA/QC laboratories and audits.
	Cindy Walters is currently the Quality Manager responsible for Supplier Quality, Incoming/In-Process/Final Inspection, and Calibration activities for Boston Scientific – West Valley Operations. She has held various individual and managerial positions in Research and Development, Product Evaluation, Quality Assurance and Control, and Regulatory Affairs for companies such as Abbott Laboratories Diagnostics Division, Sterigenics, Mentor, Osteomed, Medtronic Powered Surgical Solutions, and GE Healthcare Surgery. Her background includes extensive experience in quality system development, complaints/MDR’s, inspection and test method development, design control, supplier controls, auditing, training, software validations and packaging and gamma sterilization processes. She has a B.S. degree in Chemistry from Texas Wesleyan University. Cindy is a Certified ISO 9000 Lead Assessor, Certified Quality Improvement Associate, Certified Quality Auditor, and past ASQ Certified Quality Engineer. She is a senior member of ASQ, co-founder of the ASQ Biomedical DFW Discussion Group, past member and speaker for the FDA Medical Device Industry Coalition, ASQ CQIA Trainer, and current Secretary for the ASQ Salt Lake Chapter.